# JSO: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

- Device class: 2; regulation: 21 CFR 866.1700; FDA's rule: 510(k) required
- FDA decisions: 40
- Recalls: 39 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2007: 1
- 2008: 2
- 2009: 1
- 2010: 5
- 2011: 2
- 2012: 1
- 2016: 3
- 2017: 2
- 2018: 1
- 2019: 1

## Most-cited predicates
- K972359: Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin (1997), cited by 6
- K042812: Bblchromagar Mrsa (2004), cited by 4
- K081212: Mrsaselect - Extended Incubation (2008), cited by 2
- K122187: Vreselect Culture Medium (2012), cited by 2
- K092819: Remel Spectra Vre (2010), cited by 2
- K100589: Mrsa Select - Skin and Soft Tissue Wound Specimens (2010), cited by 2
- K091025: Chromid Vre Agar, Model: Ref 43 851 (2010), cited by 1
- K964560: Bhi W/Vancomycin Agar (1997), cited by 1
- K070361: Mrsaselect (2007), cited by 1
- K941444: Bhi Agar with Vancomycin (1994), cited by 1

Source page: https://510kreport.com/product-code/JSO
Data by year (CSV): https://510kreport.com/product-code/JSO.csv